YUSIMRY FDA label update (2026-10-12)

What To Know

This is the FDA drug label (YUSIMRY, an adalimumab product) updated record describing the drug’s approved indications, boxed warnings, and prescribing details.

The label lists approved uses including treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years and older, and ulcerative colitis in adults; it also reiterates serious infection and malignancy boxed warnings common to TNF blockers and prescribing precautions such as TB testing.

The document is a regulatory drug-label update (full text available) and does not present new trial results. It summarizes approved indications, limitations of use (including reduced effectiveness in patients who lost response or were intolerant to TNF blockers), safety warnings, and monitoring recommendations.

If you take or prescribe adalimumab (YUSIMRY), the most relevant parts are the indications, boxed warning about serious infections and malignancy, TB testing and monitoring guidance, and age-specific approvals noted in the label.

For detailed, personalized decisions (starting, stopping, switching, pregnancy, or managing infections) talk with your prescribing clinician; the label is meant to inform clinical decision-making rather than replace individualized medical advice.